Back to resultsAchilles Tendon Elongation and Gait Pattern After Rupture.
Primary Purpose
Achilles Tendon Rupture
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Individualized treatment of Acute Achilles tendon rupture.
Non-operative treatment
Operative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture
Eligibility Criteria
Inclusion Criteria:
- Appointment in the Outpatients Department within 4 days of injury.
- Total Achilles tendon rupture.
- Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
- The patient must be expected to be able to attend rehabilitation and postexamination.
- The patient must be able to speak and understand Danish.
- The patient must be able to give informed consent.
Exclusion Criteria:
- Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
- Previous rupture of the Achilles tendon in any of the two legs.
- Treated with fluoroquinolones or corticosteroids within the last 6 months.
- In medical treatment of diabetes.
- Suffers from rheumatic disease.
- Other conditions prior to the injury resulting in reduced function of any of the two legs.
- Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
- Inability to lie in prone position on the operating table.
- Terminal illness or severe medical illness: American Society of Anaesthesiologists physical status classification score higher than or equal to 3.
Sites / Locations
- Department of Physiotherapy and Orthopedical surgery, Copenhagen University Hospital, Amager-Hvidovre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Individualized treatment
Control group 1
Control group 2
Arm Description
The ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast after surgery. The ankle is held at maximal plantar flexion. Weight bearing is not allowed. After 3 weeks the cast is removed and the injured leg is transferred to a functional brace with 3 heel wedges. The patient will follow standard functional rehabilitation and the follow-up evaluations.
For the patients allocated to non-operative treatment the injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.
The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.
Outcomes
Primary Outcome Measures
Three-Dimensional Gait Analysis: Ankle peak power during push-off.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Secondary Outcome Measures
Copenhagen Achilles Length Measure
The examination of both the total and the free part of the achilles tendon of both the injured and un-injured leg is performed. The total length of the tendon is defined under the description of the intervention. The free part of the achilles tendon is defined as the distance between the proximal border of calcaneus and the musculotendinous junction of the soleus muscle and the achilles tendon. The method will be used both diagnostically for the individualized treatment and as a secondary endpoint.
Three-Dimensional Gait Analysis: Ankle peak power during push-off
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Three-Dimensional Gait Analysis: Maximal dorsiflexion in the stance phase.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Three-Dimensional Gait Analysis: stiffness of the plantar flexor musculo-tendinous complex during dorsiflexion.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Three-Dimensional Gait Analysis: time of heel-lift
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Three-Dimensional Gait Analysis: jumping up and down
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Balance measurement
The postural sway with patient standing on a force plate in the gait laboratory.
Full Information
NCT ID
NCT03543943
First Posted
May 3, 2018
Last Updated
March 15, 2022
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03543943
Brief Title
Achilles Tendon Elongation and Gait Pattern After Rupture.
Official Title
Achilles Tendon Elongation and Gait Pattern After Rupture: A Three Armed Randomized Controlled Trial Comparing an Individualized Treatment Algorithm vs. Operative or Non-operative Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively).
The individualized treatment algorithm is based on ultrasonographic status of tendon overlap and Copenhagen Achilles Length Measure (1). Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The posterior site of the achilles tendon region is covered by dark tape during the functional assesments.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individualized treatment
Arm Type
Experimental
Arm Description
The ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast after surgery. The ankle is held at maximal plantar flexion. Weight bearing is not allowed. After 3 weeks the cast is removed and the injured leg is transferred to a functional brace with 3 heel wedges. The patient will follow standard functional rehabilitation and the follow-up evaluations.
Arm Title
Control group 1
Arm Type
Active Comparator
Arm Description
For the patients allocated to non-operative treatment the injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.
Arm Title
Control group 2
Arm Type
Active Comparator
Arm Description
The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.
Intervention Type
Procedure
Intervention Name(s)
Individualized treatment of Acute Achilles tendon rupture.
Intervention Description
The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon [1]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively.
Intervention Type
Procedure
Intervention Name(s)
Non-operative treatment
Intervention Description
Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
Intervention Type
Procedure
Intervention Name(s)
Operative treatment
Intervention Description
Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
Primary Outcome Measure Information:
Title
Three-Dimensional Gait Analysis: Ankle peak power during push-off.
Description
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Time Frame
12 months after started treatment.
Secondary Outcome Measure Information:
Title
Copenhagen Achilles Length Measure
Description
The examination of both the total and the free part of the achilles tendon of both the injured and un-injured leg is performed. The total length of the tendon is defined under the description of the intervention. The free part of the achilles tendon is defined as the distance between the proximal border of calcaneus and the musculotendinous junction of the soleus muscle and the achilles tendon. The method will be used both diagnostically for the individualized treatment and as a secondary endpoint.
Time Frame
6 and 12 months after started treatment.
Title
Three-Dimensional Gait Analysis: Ankle peak power during push-off
Description
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Time Frame
6 months after started treatment.
Title
Three-Dimensional Gait Analysis: Maximal dorsiflexion in the stance phase.
Description
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Time Frame
6 and 12 months after started treatment.
Title
Three-Dimensional Gait Analysis: stiffness of the plantar flexor musculo-tendinous complex during dorsiflexion.
Description
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Time Frame
6 and 12 months after started treatment.
Title
Three-Dimensional Gait Analysis: time of heel-lift
Description
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Time Frame
6 and 12 months after started treatment.
Title
Three-Dimensional Gait Analysis: jumping up and down
Description
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
Time Frame
6 and 12 months after started treatment.
Title
Balance measurement
Description
The postural sway with patient standing on a force plate in the gait laboratory.
Time Frame
6 and 12 months after started treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Appointment in the Outpatients Department within 4 days of injury.
Total Achilles tendon rupture.
Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
The patient must be expected to be able to attend rehabilitation and postexamination.
The patient must be able to speak and understand Danish.
The patient must be able to give informed consent.
Exclusion Criteria:
Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
Previous rupture of the Achilles tendon in any of the two legs.
Treated with fluoroquinolones or corticosteroids within the last 6 months.
In medical treatment of diabetes.
Suffers from rheumatic disease.
Other conditions prior to the injury resulting in reduced function of any of the two legs.
Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
Inability to lie in prone position on the operating table.
Terminal illness or severe medical illness: American Society of Anaesthesiologists physical status classification score higher than or equal to 3.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria S Hansen, PT, MSc
Organizational Affiliation
Copenhagen University Hospital, Amager-Hvidovre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiotherapy and Orthopedical surgery, Copenhagen University Hospital, Amager-Hvidovre
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan of sharing data with researchers not already included in this study.
Citations:
PubMed Identifier
25038882
Citation
Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.
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Achilles Tendon Elongation and Gait Pattern After Rupture.
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